Company ยท US
Spire Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2008. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
48recalls (0 in 12 months)
48recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2008 | K073092 | DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40, Spire Biomedical, Inc. | MSD |
| Jan 22, 2008 | K073093 | DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36, Spire Biomedical, Inc. | MSD |
| Feb 12, 2007 | K063441 | 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55 Spire Biomedical, Inc. | MSD |
| Jan 29, 2007 | K063431 | 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40 Spire Biomedical, Inc. | MSD |
| Dec 5, 2006 | K062435 | REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS Spire Biomedical, Inc. | NFK |
| Sep 1, 2006 | K060288 | RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS Spire Biomedical, Inc. | MSD |
| May 9, 2006 | K060155 | 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Dec 3, 2004 | K042858 | 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Jul 30, 2004 | K041559 | 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 Spire Biomedical, Inc. | MSD |
| Apr 19, 2004 | K040509 | ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 Spire Biomedical, Inc. | MSD |
| Dec 23, 2003 | K032061 | DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH Spire Biomedical, Inc. | MSD |
| Nov 6, 2002 | K022644 | RETRO REPAIR KIT, MODEL PRRK5 Spire Biomedical, Inc. | NFK |
| Oct 11, 2002 | K022620 | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT Spire Biomedical, Inc. | FKA |
| Jul 19, 2002 | K022000 | POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) Spire Biomedical, Inc. | MSD |
| May 17, 2002 | K021212 | 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS Spire Biomedical, Inc. | MSD |
| Apr 11, 2002 | K013160 | POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER Spire Biomedical, Inc. | MSD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM ALTA LR GOLD STD KIT
Model: ALC50SH55
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM ALTA LR GOLD STD KIT
Model: ALC35SH40
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR GOLD STD KIT
Model: ALC31SH36
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR GOLD STD KIT
Model: ALC27SH32
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR GOLD STD KIT
Model: ALC23SH28
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit con Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR GOLD STD KIT
Model: ALC19SH24
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA EXCHANGE
Model: AL27SH32 XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA EXCHANGE KIT
Model: AL23SH28 XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex
free. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA EXCHANGE KIT
Model: AL19SH24-XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR STANDARD KIT
Model: AL31NH36
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheres Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR STANDARD KIT
Model: AL27NH32
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT
Model: AL23NH28
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR STANDARD KIT
Model: AL19NH24
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM ALTA LR STANDARD KIT
Model: AL35SH40
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR STANDARD KIT
Model: AL31SH36
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR STANDARD KIT
Model: AL27SH32
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT High Flow Recirculation
Model: AL23SH28
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemod Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter
Model: AL19SH24
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chron Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON GOLD FUNNEL TIP STD KIT
Model: DFC27SH32
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic
hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC23SH28 and DFC23SH28-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuf Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC19SH24 and DFC19SH24-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cu Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM DECATHLON GOLD STD KIT
Models: DEC50SH55 and DEC50SH55-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM DECATHLON GOLD STD KIT
Models: DEC35SH40 and DEC35SH40-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM DECATHLON GOLD STD KIT
Models: DEC31SH36 and DEC31SH36-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
h Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON GOLD STD KIT
Models: DEC27SH32 and DEC27SH32-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON GOLD STD KIT
Models: DEC23SH28 and DEC23SH28-K Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON GOLD STD KIT
Models: DEC19SH24 and DEC19SH24-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON EXCHANGE KIT
Model: DX27SH32-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON EXCHANGE KIT
Model: DX23SH28-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +3 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON EXCHANGE KIT
Model: DX19SH24-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON MINI KIT
Model: DM27SH32
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit c Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON MINI KIT
Model: DM23SH28
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON MINI KIT
Model: DM19SH24
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON FUNNEL TIP CATHETER
Model: DF27SH32-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON FUNNEL TIP CATHETER
Model: DF23SH28-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON FUNNEL TIP CATHETER
Model: DF19SH24-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM DECATHLON FUNNEL TIP STD KIT
Model: DF50SH55
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM DECATHLON FUNNEL TIP STD KIT
Model: DF35SH40
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM DECATHLON FUNNEL TIP STD KIT
Model: DF31SH36
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON FUNNEL TIP STD KIT
Model: DF27SH32
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON FUNNEL TIP STD KIT
Model: DF23SH28
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON FUNNEL TIP STD KIT
Model: DF19SH24
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM DECATHLON STD KIT
Models: DE50SH55 and DE50SH55-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM DECATHLON STD KIT
Models: DE35SH40 and DE35SH40-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM DECATHLON STD KIT
Models: DE31SH36 and DE31SH36-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit 28cm Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON STD KIT
Models: DE27SH32 and DE27SH32-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON STD KIT
Models: DE23SH28 and DE23SH28-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON STD KIT
Models: DE19SH24 and DE19SH24-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |